Permedica S.p.A

Permedica S.p.A. specializes in medical devices primarily used in orthopedic and dental procedures. Their key products include reusable acetabulum prosthesis trials (such as tibial components and patellar wings), prefabricated trial components for hip arthroplasty, reusable instrument trays, and single-use dental implant suprastructures like temporary preformed abutments. These devices are designed to assist surgeons during trial fitting and surgical planning.

Permedica S.p.A. is headquartered in Italy, which means its devices are subject to European Union medical device regulations. Since the company manufactures products classified as Class I and Class IIa, they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. Their devices are listed in the EUDAMED database, which is the official EU registry for medical devices, ensuring transparency and traceability under EU regulatory requirements.

Permedica S.p.A.’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry is maintained by the European Medicines Agency (EMA) and is used to track device information, including manufacturer details, classifications, and regulatory status, ensuring compliance with EU medical device regulations.

Permedica S.p.A.’s devices fall into two primary classification categories under EU regulations: Class I and Class IIa. Class I devices are generally considered low-risk, such as reusable instrument trays, while Class IIa devices, like acetabulum prosthesis trials and certain trial components, carry a slightly higher risk and require additional regulatory scrutiny, including conformity assessment procedures to ensure safety and performance.